The Senior/Principal Medical Writer is responsible for the medical writing deliverables that support the clinical oncology portfolio at Boston Biomedical Inc. The Senior/Principal Medical Writer will assist in preparing moderately complex clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure), and sections of regulatory submissions. As a key member of the Clinical Study Team, the Senior/Principal Medical Writer will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in the preparation of clinical regulatory documents.
Reporting Relationship: Associate Director, Medical Writing
- Draft, edit, format, and finalize documents including, but not limited to: clinical protocols and amendments, investigator’s brochures (IBs), clinical study reports (CSRs) and development safety update reports (DSURs).
- Provide quality control (QC) review of clinical and regulatory documents including data output.
- Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
- Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
- Facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors.
- Assisting in the development of templates and standard operating procedures (SOPs).
- Representing Medical Writing on one or more programs.
Professional Experience / Qualifications
- Advanced degree (MS or PhD) in a relevant scientific field.
- 3-5 years medical writing experience in a pharma, biotech, or a combination of CRO and pharmaceutical setting with in-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Strong written and verbal communication skills, with the ability to clearly present clinical data.
- Regulatory submissions and knowledge of eCTD formatting preferred.
- Oncology experience strongly preferred.
- Experience working in a fast-paced environment.
Job Location: Cambridge, MA
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